The clinical cure rate was 89.5% with 3 days of treatment and 89.9% with 5 days of treatment. The absolute difference was 0.4 (95% confidence interval, CI: -2.1 - 3.0; p not significant).
Among wheezers and non-wheezers, the clinical cure rates on day 5 were similar for 3 and 5 days' treatment. The cure rates were 90.7% for wheezers versus 89.1% for non-wheezers with 3 days' treatment, and 89.8% (wheezers) and 90.0% (non-wheezers), respectively, with 5 days' treatment.
There were 225 (10.3%) clinical failures.
Clinical failure was associated with:
isolation of respiratory syncytial virus (adjusted odds ratio 1.95, 95% CI: 1.0 - 3.8),
excess respiratory rate of greater than 10 breaths/minute (adjusted odds ratio 2.89, 95% CI: 1.83 - 4.55), and
nonadherence with treatment at day 5 (adjusted odds ratio 11.57, 95% CI: 7.4 - 18.0).
Adherence to the treatment regimen was 94% for the 3-day treatment and 85% for the 5-day treatment.
Adverse reactions were similar in both treatment arms. There were no deaths, purpura or serious adverse effects of amoxicillin.
The relapse rate after day 5 was 5.3% with 3 days' treatment and 4.4% with 5 days' treatment. The absolute difference was 1.0 (95% CI: -1.0 - 3.0; p not significant).
On day 14, the isolation rates of S. pneumonia and H. influenza were 10.9% (n=325) and 6.9% (n=249), respectively. The rates did not differ according to the type of treatment.
There was no change in resistance of H. influenza over time. However, the proportion of S. pneumonia isolates resistant to co-trimoxazole rose significantly from 66.1 to 78.2%, (p=0.02), over 15 days in the 5-day amoxicillin treatment group.
There was no increase in the emergence of antimicrobial resistance in S. pneumonia or H. influenza in individual patients.
Of the 1,963 children assessed as clinically cured, mothers or caregivers reported that 51.2% were completely well, 47.8% were improved but still sick, 1.3% were the same, and 0.1% were worse. Of the 96 patients assessed as not cured, mothers reported that 4.2% were completely well, 63.5% were improved but still sick, 29.2% were the same, and 3.1% were worse, (p=0.001).